Non-small cell lung cancer recurrent TNM clinical staging | Non-Small Cell Lung Carcinoma Progressive TNM clinical staging | Chemotherapy | Status post Gefitinib failed
Item
recurrent or progressive non-small cell lung cancer (nsclc) stage iv or iiib patients after chemotherapy following gefitinib failure
boolean
C0278517 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2,1])
C0205329 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3])
C0231290 (UMLS CUI [4,1])
C1122962 (UMLS CUI [4,2])
C0231175 (UMLS CUI [4,3])
Age
Item
male and female patients aged over 18 years
boolean
C0001779 (UMLS CUI [1])
WHO performance status scale
Item
world health organization (who) performance status 0-2 (those with performance status 2 must have been stable with no deterioration over the previous 2 weeks)
boolean
C1298650 (UMLS CUI [1])
Stable Disease | Prior Therapy Gefitinib
Item
had at least stable disease with previous gefitinib treatment
boolean
C0677946 (UMLS CUI [1])
C1514463 (UMLS CUI [2,1])
C1122962 (UMLS CUI [2,2])
Antineoplastic Agent Therapy Quantity | Status post Gefitinib failed | EGFR Tyrosine Kinase Inhibitors | Erlotinib Excluded
Item
had at least one anticancer agent therapy after gefitinib failure ;following treatment with another epidermal growth factor receptor (egfr) tyrosine kinase inhibitors (tkis)- erlotinib or other tkis should not be included in anticancer agent therapy.
boolean
C2346834 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C1122962 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C1443775 (UMLS CUI [3])
C1135135 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
Indication Gefitinib | Second line treatment Non-small cell lung cancer recurrent | Third line treatment Non-small cell lung cancer recurrent | Second line treatment Non-small cell lung cancer metastatic | Third line treatment Non-small cell lung cancer metastatic
Item
the current approved indication of gefitinib is 2nd or 3rd line monotherapy for recurrent or metastatic nsclc. however, in practice with off-label indication, it can also be used as a 1st line treatment at the patient's own expenses. thus, in this trial gefitinib retreatment will be 3rd line or more.
boolean
C3146298 (UMLS CUI [1,1])
C1122962 (UMLS CUI [1,2])
C1710038 (UMLS CUI [2,1])
C0278517 (UMLS CUI [2,2])
C2986605 (UMLS CUI [3,1])
C0278517 (UMLS CUI [3,2])
C1710038 (UMLS CUI [4,1])
C0278987 (UMLS CUI [4,2])
C2986605 (UMLS CUI [5,1])
C0278987 (UMLS CUI [5,2])
Measurable lesion | Prior radiation therapy Absent Measurable lesion Quantity | Exception Disease Progression
Item
measurable lesion according to response evaluation criteria in solid tumors(recist) with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
boolean
C1513041 (UMLS CUI [1])
C0279134 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1513041 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0242656 (UMLS CUI [3,2])
Informed Consent
Item
provision of written informed consent
boolean
C0021430 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
Lung Diseases, Interstitial
Item
evidence of clinically active interstitial lung diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
boolean
C0206062 (UMLS CUI [1])
Life Expectancy
Item
expected life expectancy less than 2 months
boolean
C0023671 (UMLS CUI [1])
Severe allergy Gefitinib | Severe allergy Gefitinib Excipient
Item
known severe hypersensitivity to gefitinib or any of the excipients of this product
boolean
C2945656 (UMLS CUI [1,1])
C1122962 (UMLS CUI [1,2])
C2945656 (UMLS CUI [2,1])
C1122962 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Resolution Lacking | Toxicity chronic CTCAE Grades | Etiology Cancer treatment
Item
any unresolved chronic toxicity greater that common terminology criteria (ctc) grade 2 from previous anticancer therapy
boolean
C1514893 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0600688 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C0920425 (UMLS CUI [3,2])
Systemic disease Severe | Systemic disease Uncontrolled | Respiration Disorder Unstable | Heart Disease Unstable | Liver disease Unstable | Kidney Disease Unstable | Respiration Disorder Uncompensated | Heart Disease Uncompensated | Liver disease Uncompensated | Kidney Disease Uncompensated
Item
as judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0442893 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0035204 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0018799 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0023895 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0022658 (UMLS CUI [6,1])
C0443343 (UMLS CUI [6,2])
C0035204 (UMLS CUI [7,1])
C0205433 (UMLS CUI [7,2])
C0018799 (UMLS CUI [8,1])
C0205433 (UMLS CUI [8,2])
C0023895 (UMLS CUI [9,1])
C0205433 (UMLS CUI [9,2])
C0022658 (UMLS CUI [10,1])
C0205433 (UMLS CUI [10,2])
Serum bilirubin increased
Item
serum bilirubin greater than 3 times the upper limit of reference range (ulrr)
boolean
C0859062 (UMLS CUI [1])
Aspartate aminotransferase increased | Alanine aminotransferase increased | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver Present
Item
aspartate aminotransferase (ast/sgot) or alanine aminotransferase (alt/sgpt) ≥ 2.5 x upper limit normal (uln) if no demonstrable liver metastases (or >5 x in presence of liver metastases)
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0494165 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0494165 (UMLS CUI [4,1])
C0150312 (UMLS CUI [4,2])
Disease Clinical Significance Study Subject Participation Status Unfavorable | Laboratory test finding Study Subject Participation Status Unfavorable
Item
evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3640815 (UMLS CUI [1,4])
C0587081 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C3640815 (UMLS CUI [2,3])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods
Item
pregnancy or breast-feeding women (women of child¬bearing potential). women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Operative Surgical Procedures Absent CNS metastases | Therapeutic radiology procedure Absent CNS metastases
Item
newly diagnosed central nervous system (cns) metastases that have not yet been treated with surgery and/or radiation. patients with previously diagnosed and treated cns metastases or spinal cord compression may be considered if they have evidence of clinically stable disease (no steroid therapy or steroid dose being tapered) for at least 2 weeks
boolean
C0543467 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0686377 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0686377 (UMLS CUI [2,3])